Establishing user centre design in developing a lung cancer self- management digital platform: Protocol Paper

doi:10.21203/rs.3.rs-4686829/v1

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Establishing user centre design in developing a lung cancer self- management digital platform: Protocol Paper

https://doi.org/10.21203/rs.3.rs-4686829/v1

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Lung cancer exemplifies a significant global health challenge, characterised by pronounced mortality rates. An escalating incidence of new cases worldwide, coupled with comparatively diminished survival rates, distinguishes it from other prevalent malignancies.

Physical activity can alleviate symptoms of breathlessness, cough, and depression, while also enhancing well-being in individuals with lung cancer. However, resources to support self-management through physical activity and exercise are limited. Our team proposes an innovative solution: a digital self-management platform designed for individuals with lung cancer.

This paper reports on a protocol for the co-development of an exercise focused digital self-management platform. The principal objective of this platform is to offer people living with lung cancer an alternative approach to accessing relevant support to manage their health more independently, thereby fostering a more self-reliant approach to physical health self-management. The platform offers users with a secure internet connection, an individually tailored exercise plan, with features that facilitate the ongoing monitoring of their progress. Furthermore, the platform offers relevant guidance to users by directing them toward pertinent resources as required.

The protocol describes a procedural framework for the platform's development and sets out a comprehensive strategy for the iterative co-development of the app with key stakeholders; lung cancer patients/survivors and their carers, health care professionals and other key decision makers. The platform's development is rooted in a user-centred, coproduction approach, aimed at accommodating the intricate demands of the targeted patient demographic and enhancing their overall physical functioning and wellbeing outcomes. A mixed methods study design is employed to collect both qualitative and quantitative data throughout the study.

Lung cancer

digital health

self-management

physical activity

quality of life

co-development

user involvement

protocol

Lung cancer ranks as the second most common cancer globally with over 2.2 million new cases diagnosed in 2020 (1). Projections indicate that this number will continue to rise (2). People living with lung cancer often experience significant symptom burdens and unmet needs across the course of the disease (3). Common symptoms include fatigue, breathlessness, and depression, all of which can be reduced through exercise interventions (4). Additionally, about two-thirds of lung cancer patients have at least one comorbidity, and up to half experiencing e multiple co-morbid conditions (5). Less than a third of lung cancer patients adhere to recommended exercise guidelines, which advocate reducing sedentary time, building strength and balance, and engaging in 150 minutes of aerobic activity weekly. (6). Recently, the United Kingdom’s (UK) National Institute for Health and Care Excellence (NICE) recognised exercise as a fundamental strategy for healthcare and holistic disease management (7). However, in the absence of a comprehensive national rehabilitation system and an overstretched healthcare workforce this strategy remains challenging to deliver on.

Patient self-management can play a pivotal role in improving health outcomes. Cancer survivors often adopt self-management practices to improve their health and well -being (8). By adapting activities like medication and dietary adherence, exercise management, and other disease-specific behaviours they can strive to reduce the detrimental effects of their condition on both their physical, psychological and overall well-being, while maintaining control over their illness (8, 9).

Web-based interventions have gained popularity in recent years, allowing users to independently access recommended online programs through websites for health and well-being improvement (10). The COVID-19 pandemic highlighted the benefits of digital technology with studies showing that home-based rehabilitation can boost patient adherence and health related quality of life (QoL) outcomes (11).

A recent systematic review undertaken by the authors revealed that although an expanding body of empirical data lent support to the integration of technology-based interventions in healthcare, their utilisation within the UK NHS remained suboptimal. Specifically, there is a notable lack of evidence-based mobile health (mHealth) and electronic health (eHealth) interventions designed to enhance exercise and physical activity for lung cancer patients. Moreover, existing cancer-related applications (apps) rarely offer personalised approaches to physical activity and exercise that consider individual patient preferences and needs (12).

To address this gap. researchers are developing a new exercise based digital health platform for people with lung cancer by building on previous work undertaken at the participating university and combining the HandHeld Health and iExhale platforms. iExhale is a web-based app, co-developed with lung cancer patients to increase physical activity and improve symptoms (13, 14). The HandHeld Health app, a native app for Android and iOS was developed for patients with coronary obstructive airway disease (COPD) and received medical devices accreditation (MDD Class 1). These two apps will be integrated and hosted on the existing HandHeld Health server. Further development of the combined app will be guided by the app rating inventory (15), which scores an app according to evidence, content and customisability. The agile framework for software development (16) and the COM-B (17) behaviour change model will underpin the apps further development.

1. To develop the content and features of athe new digital self-management platform through integration of two other applications iExhale and HandHeld Health, with enhancements from the app developer, and findings from a recently completed systematic literature review (12). The app will undergo further development based on the insights from focus groups and/or interviews with health care professionals, people with lung cancer and their carers’, and other stakeholders throughout the development process.
2. To assess the platform’s acceptability, practicality, and self-efficacy.

Aim 1

Integration

The researchers will work with an app developer to integrate the content and features of the iExhale and HandHeld Health apps (Fig. 1). Enhancements will only be made to ensure that the app flows seamlessly and content will not be edited. The clickable prototype (18) of the new app will allow navigation through the app to enable visualisation of the user experience and flow, ensuring that all features are fully integrated. This version of the app will be made available for further development phases.

Focus Groups/Interviews:

Recruitment: The researchers will recruit 24–36 participants into the focus group study. Participants will be alerted to the study through notices and adverts, circulated via professional networks, cancer charities, and social media platforms. People who reach out to the researchers and express an interest in taking part in the study will be sent a participation information sheet (PIS) and will be invited to provide written informed consent, online via Qualtrics. They will then be sent a link to the clickable prototype of the new app.

Focus Group/Interviews: 4–6 online focus group sessions will be hosted via Zoom. The researchers will offer potential participants an additional meeting to ensure they are able use the online Zoom platform, allay any anxiety about participation in a focus group and answer any questions that may arise.

At least two focus groups will be conducted with patients and carers (n = 12–18) and two with healthcare professionals (n = 12–18). Group sizes will not exceed eight participants, as this is considered optimum to encourage discussions and manage the meeting within the allocated time (19). Health Care Professionals (HCPs) and patients/carers will be allocated to different focus groups. For participants who cannot and do not want to be part of a focus group the researchers will offer individual interviews via Zoom. All sessions will be digitally recorded, and the focus of the group discussions will remain on the development and optimisation of the app, allowing participants to explore their own and others’ experiences collectively and providing them with the opportunity to verify and consolidate their ideas and views with one another. At least two researchers will be present at each focus group session. One will facilitate while the other takes notes and acts as a moderator.

Analysis: The Zoom auto transcript function will be employed. Transcripts will be checked for accuracy and de- identified before analysis. Data from transcripts, recordings and notes will be thematically analysed using the Framework method (20).Themes that emerge will then be mapped against the APA App evaluation framework(21) and the COM-B behaviour change framework (22) to identify areas for further improvement to the new app.

App Adaptation

Findings will be shared with the app developer and the app will be edited. A record of desirable edits will be maintained for use in further development work when more funding is available.

Aim 2

Usability Study:

Setting: The usability study will be undertaken face to face on university premises during core office hours. The cost of travel, accommodation and subsistence will be reimbursed.

Inclusion Criteria: Only participants who meet the following criteria will be included in the usability study.

≥ 18 years of age
Able to speak EnglishHave a confirmed diagnosis of lung cancerAble to provide written informed consentMust own a smartphoneHas an ECOG performance status ≤ 1 (They may be restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work)

Exclusion Criteria:

Participants who are not well enough to attend the university site
Participants who are unable to undertake unsupervised exercise.

Recruitment: Lung cancer patients who are involved in the phase one focus group study and meet the above eligibility criteria will be invited to take part; the researchers will also invite further participants via charities and social media using notices and adverts. Potential participants will be sent a participant information sheet via post or email that will outline the purpose of the study and the study procedures. The lead researcher will contact participants via email or telephone a week later to confirm participation and arrange for the participant to attend the university site to provide written informed consent and take part in the usability study.

A minimum of ten participants will be recruited which is sufficient for maximising the expected level of problem discovery (23) and participants will combine task-based activities with participant interviews in three phases.

Phase 1

Participants will be invited to a face-to-face meeting at the university site. Following consent, participants will be asked to fill out a preliminary questionnaires on; basic demographic information, how they currently use their smartphones, as well as the Mobile Device Proficiency Questionnaire (MDPQ-16), which is designed to evaluate how skilled older adults are with mobile devices(24). Participants will be given a brief introduction to the system to familiarise them with its purpose and structural elements, but they will not be provided with guidance on how to use the user interface. Thereafter, participants will use the prototype of the HHH- LC app in a simulated environment. Sessions will last no more than one hour and participants will be encouraged to “Think aloud” as they navigate the platform and highlight areas for improvement (25). This will capture data on the participants experiences. The user interaction with the platform will be recorded (audio and video). The video will only focus on the upper limbs. The researcher will monitor the participants closely and keep a record of the users’ interaction with the device. On completion of the task the researcher will evaluate participants’ task performances using the pre-agreed assessment criteria along with the option to provide additional comments. On completion of the usability task, participants will complete a post-test survey using the System Usability Scale, a ten-item scale that provides a comprehensive evaluation of usability and a user-centred subjective perception of interacting with a system (26). The participants will then get the opportunity to use the app at home for two weeks.

Phase 2

Participants will test the application in their home environment for two weeks and use it as instructed. After this period, they will be invited for a one-to-one semi-structured interview over Zoom. Interviews will last around 30-minutes and will be digitally recorded and later transcribed.

App Adaptation

An assessment of the apps usability will be undertaken in two distinct phases, employing qualitative and quantitative research methodologies. Data from both phases will be analysed. Interviews will be analysed thematically using the framework method and mapped against the APA and COM-B frameworks. Descriptive statistics will be produced for quantitative metrics and examined against literature on thresholds for acceptability (usability), accuracy (completion and error rates) and efficiency (task-times). The findings will be fed back to the app developer to enable further improvements to be made to the app

Study Design

This study adopts a mixed method, pragmatic study design. Quantitative data will be collected from surveys and measurements undertaken during a simulated exercise and qualitative data will be obtained via talk out loud activities within simulated sessions and qualitative interviews with participants.

The platform's development adheres to an agile framework (Fig. 2), a widely adopted methodology in software development (9). This approach systematically deconstructs the project into distinct phases, including planning, design, development, testing, deployment, and review. It operates as an iterative process, facilitating continual adaptation throughout various stages of product development. This approach enables collaborative engagement between developers, researchers, and stakeholders, ensuring that the product is constructed, refined, and enhanced in a timely and efficient manner, thus facilitating continuous product improvement.

User Centred Design

This approach will empower end users to influence the design and development process, resulting in greater acceptability, improved adherence, and the ability to engage in remote self-management practices. As a result, this approach has the potential to reduce the clinical pressures on healthcare providers and enhance the management of disease and well-being of lung cancer patients.

The new app, HandHeld Health – Lung Cancer represents an endeavour to harness the potential of a digital platform in assisting individuals with lung cancer to enhance their physical and psychological well-being and improve the symptoms of their disease. Our approach employs intense user involvement in the co-production of the platform, to generate new ideas and to ensure that the new app meets the complex needs of our target population. We anticipate with the significant contributions of end users in the development phase we are more likely to yield a product that is acceptable to people living with lung cancer, their carers, and the health care professionals caring for them. Furthermore, themes derived from the dataset will enhance the researchers' understanding of the app's utility and usability and support decisions on how to undertake the planned follow-on feasibility study. The feasibility study will aim to establish the feasibility of employing a digital platform that recommends a personalised exercise plan to improve the physical functioning and well-being of individuals with lung cancer.

Limitations

First, the population sample may not accurately represent the broader lung cancer cohort. Participants used the app at home for only two weeks, so we cannot determine how usability findings might change with longer-term use. Additionally, the recruitment strategy may result in a sample biased towards individuals who are more digitally adept and physically fitter than the average lung cancer patient, which could affect the study's generalisability.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

Oxford Brookes Knowledge Exchange Award

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No competing interests reported.

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You are reading this latest preprint version

Establishing user centre design in developing a lung cancer self- management digital platform: Protocol Paper

Status:

Version 1

Abstract

Figures

Background

Study Aims

Integration

Focus Groups/Interviews:

Usability Study:

Exclusion Criteria:

Phase 1

Phase 2

Methods

Discussion

Declarations

References

Additional Declarations

Status:

Version 1